EU Authorised Representative
The EU Authorised Representative (EUAR) role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.
Since the MDR and IVDR Regulations were introduced the role of the EUAR has become wider in scope and responsibilities.
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Article 11 MDR and IVDR
Article 11 of the MDR and the IVDR sets out the requirements and responsibilities of an EUAR and include the following:
Non-member state-based manufacturers:
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole Authorised Representative.
Responsibility:
Where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10 (Manufacturers Responsibilities), the Authorised Representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
An EUAR who terminates its mandate shall immediately inform the Competent Authority of the Member State in which it is established and, where applicable, the Notified Body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.
Changing an Authorised Representative:
The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:
- the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
- the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
- the transfer of documents, including confidentiality aspects and property rights;
- the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.
Mandate:
The designation shall constitute the Authorised Representative’s mandate, it shall be valid only when accepted in writing by the EUAR and shall be effective at least for all devices of the same generic device group.
The EUAR shall perform the tasks specified in the mandate agreed between it and the manufacturer. The EUAR shall provide a copy of the mandate to the competent authority, upon request.
Mandated Tasks:
Verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
in response to a request from a Competent Authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
forward to the manufacturer any request by a competent authority of the Member State in which the Authorised Representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
terminate the mandate if the manufacturer acts contrary to its obligations under the Regulation.
How can Patient Guard help you?
Patient Guard under its subsiduary company, Patient Guard Europe UG, which is based in Neuhausen auf den Fildern, Germany, provides Authorised Representative services. We have helped many Medical Device manufactures who are not based in an EU member country register their medical devices in Europe. To find out more about how Patient Guard can help register your Medical Device Product in the EU click on the button below.
